An HIT Moment with ... is a quick interview with someone we find interesting. Greg Smith is a Certified Product Safety Project Engineer (NCE) and quality assurance manager for the MET SE Headquarters.

Your article, Not Suitable for Medical Use, suggests that special interests pressured OSHA to allow medical devices with unproven electrical safety to be used in the OR. How did that happen?

There are a combination of reasons that contribute to this, but the main reason is a perception that having this equipment correctly built and tested to national and international safety standards is too expensive. In reality, having a compliant product certified can cost as little as $5,000-$10,000, then between $2,000-$4,000 a year for testing laboratory audits to make sure the manufacturer is still building the units per the certification report and performing electrical safety testing before the equipment leaves the factory.

This cost, when adjusted to the hundreds and thousands of, for example, computers, is not a significant cost factor. The fact is, sometimes it costs more that this because these manufacturers are turning out non-compliant and hazardous equipment. We see this every day in the testing lab and during the unannounced factory inspections during the year. Our records show that if manufacturers were allowed to "get it right" on their own, they will, in most cases, not get it right. Most manufacturers making a product for the first time do not even know what standards apply to their products.

These special interest groups are pressuring OSHA, along with elected officials who know nothing about electrical safety. At the same time, electrical safety experts are constantly reminding OSHA about the reasons why this is a Federal requirement for equipment in the workplace.

There are no US regulations for imported products to be safety certified. Although the "CE" mark is legal in Europe, the EU is considering moving to a new system because they are being flooded with these "CE" self-declared products from Asia and other places. Why would we move to something like the SDoC (Supplier Declaration of Conformity) when this system is showing problems over time in other parts of the world?

Simply put, these groups want to speed up time-to-market at any expense. In this case, it is at the expense of safety for US consumers and workplace owners. Here is a great article on SDoC.

What are some real-life examples in uncertified medical devices cause harm to patients?

Just last year, a baby was burned at a NC hospital by a non-certified incubator. Some of these incidents really stick out, especially whey they make the news. Many incidents of shock are never reported, are only sometimes recorded in the OSHA logs, and not ever reported unless OSHA has a reason to examine these logs. Also, some incidents are prevented through the diligence of our biomedical technicians, who regularly test and repair equipment.

In recent years, incidents have decreased because many hospitals require medical equipment to be certified as a condition of purchase. At some less-vigilant healthcare facilities, patients are likely killed from leakage current, although this is difficult to prove because it is simply called "death from cardiac arrest". The science of electricity and specifically leakage current tells us of the hidden dangers, especially to patients who are vulnerable (e.g. during surgery). The National and International safety standards for medical equipment are in place because of these known hazards.

A skeptic might say that you have a vested interest in raising concerns about uncertified products since you’re in the certification business. What would you say to convince them your concerns are real?

Those of us who are passionate about safety spend many personal hours addressing these problems. Electrical safety experts include electrical contractors, electrical and other government inspectors, power company engineers, design engineers, and electrical equipment manufacturers. For an unbiased view of these issues, ask some of these individuals.

For example, these issues are discussed regularly in associations like the IAEI, the International Association of Electrical Inspectors, where all types of electrical safety experts help develop consensus positions on these subjects. Go to the IAEI Web site and read some articles on product safety and the need for third party safety certifications, .

An important question here is: if we don’t ask our electrical safety experts, who are we going to ask? Would you consult a mechanic about an internal organ surgery? In a recent NC court case to exempt equipment from safety inspections, the "Code expert" for the plaintiff was a man who developed a way to get cat urine out of carpet. The electrical safety experts were ignored because science and facts are less exciting than rhetoric and hyperbole. Vested interest? There are many types. Some are based on science and a desire to keep others safe and others are based on haste and pure greed. We are in the business of product safety certifications because electricity kills people.

IT departments are often involved with choosing portable computing equipment that includes batteries and electrical connections. What should they be doing to make sure these devices are safe for use in specific hospital areas?

Purchasing departments should specify that only certified products are to be procured. There are many valid safety certification marks and agencies ("CE" is not a safety certification). In these specifications, it should be mandated that patient area equipment needs to carry a UL60601 designation.

Regular (consumer) computer equipment is designed much differently, and even if it is certified, the standards are much different. The IT Standard, UL60950, allows leakage current levels five times as high as the medicals standard, and for good reasons.

Also, consumer IT equipment is not designed for the medical environment, as with laboratory equipment and consumer TVs and appliances. There are computers and monitors specifically designed and tested for patient area use. Typically, IT departments and administrators do not know the difference. Many facilities use isolation transformers in an attempt to mitigate risk, but the equipment can be easily unplugged and leave patients and healthcare workers exposed to the risk of electric fire and shock or electrocution.

Should hospitals and practices regularly test computer equipment for safety when it is used in patient care areas?

All equipment for patient care areas should be tested on a regular basis. This equipment undergoes heavy usage and is prone to failure through wear, abuse, and environment. If the protective ground is lost, the risk increases, especially for equipment not designed for use in patient areas.

Biomedical technicians regularly see these conditions, providing safety testing and effecting repairs. These electrical safety specialists are on the front lines of patient and worker safety, and should be allowed to do their important jobs. There are regular attempts to cut this testing from budgets, so much attention needs to be paid to this profession and the unseen hazards they prevent.

Important article that brings the issue of electrical safety to our awareness. I would like to add two issues:

1. Microshock.
When a computer (such an EMR in an Operating Room or Intensive Care Unit) is connected to monitors that have an invasive component – such as CVP, Swan Ganz or Intra Arterial pressure monitors – if the equipment is not well grounded – there is a danger of MICROSHOCK. Patient’s life is in danger at a much lower electrical current leakage, actually in the order of magnitude thousands of times lower than say, regular electrical shock thru the skin. This danger is the result of the catheter(s) being inside a blood vessel and providing an excellent conducting medium – salty blood – directly to the heart. What makes the above situation even nastier – is the difficulty in making the right diagnosis, of a patient suddenly developing arrhythmias while being under anesthesia / critical care….There are so many other diagnosis to consider and so little time to react that microshock usually proves fatal.

2. Optical coupler
Years ago, when we decided to hook a printer to a monitor in the OR and that monitor had an invasive component as detailed above we employed an optical connector…It basically transfers the information using an optical mechanism, thus achieving electrical safety and still maintaining the information transfer.

Thank you for the great comments. The online version of the complete article is now available here: http://www.iaei.org/magazine/?p=4561
My bio has all my contact information in case anyone needs information on product safety.
– Greg

We would like to see development in the patient safety area for better product safety testing of information systems specifically related to patient safety. As the healthcare environment continues to move toward PC convergence and integration with EHR/EMR’s, the need for continuous quality improvement does not decrease. We have only shifted stress and created new risk complexities that require our attention.

Conclusion: Funding for safety testing should be increased in proportion to complexity. This means care and planning that can only come from understanding.

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